Phosphodiesterase-5 Inhibitor in Eisenmenger Syndrome

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A preliminary observational study by the investigators has shown that tadalafil, a selective phosphodiesterase-5 inhibitor (PDE-5) decreases pulmonary vascular resistance(PVR) in patients of eisenmenger syndrome (ES) resulting in increase in pulmonary blood flow (Qp), systemic oxygen saturation (SaO2), functional class and exercise capacity. The aim of this placebo controlled trial was to assess the effect of the drug on exercise capacity and functional class compared to placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Govind Ballabh Pant Hospital
• Treatments: Phosphodiesterase 5 Inhibitors; Tadalafil

Criteria

Inclusion Criteria:

• Patients of ES with age greater than or equal to 14 years and weight greater than or equal to 30 kgs in World Health Organisation (WHO) functional class II and III attending our congenital clinic were invited to participate in the study

Exclusion Criteria:

• WHO class IV,

• congestive heart failure or had PCWP > 15mmHg,

• left ventricular ejection fraction <40%,

• atrial fibrillation,

• patent ductus arteriosus,

• complex congenital heart defects,

• restrictive lung disease(total lung capacity < 70% of predicted), obstructive lung disease ( forced expiratory volume in 1 second [FEV1] < 70% of predicted with FEV1/ Forced vital capacity [FVC] < 60%),

• previously diagnosed coronary artery disease requiring nitrate therapy,

• abnormal biochemical profile and

• hypersensitivity to PDE- 5 inhibitors.